A Single Center, Randomized, Controlled Trial of the Safety and Efficacy of Progesterone for the Treatment of COVID-19 in Hospitalized Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale
研究概览
简要总结
The purpose of this study is to assess safety and efficacy of progesterone for treatment of COVID-19 in hospitalized men.
详细描述
Hospitalized men with COVID-19 who meet the eligibility criteria will be informed about study and the potential risks. All the patients giving written informed consent will be randomized in 1:1 ratio to progesterone (100 mg SQ twice daily) plus standard of care or standard of care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Laboratory-confirmed COVID-19 with in 72 hours prior to randomization
- •Respiratory symptoms or abnormal lung exam or abnormal chest imaging AND oxygen saturation ≤94% on room air, or requiring supplemental oxygen less than 50% high flow
- •Understands and agrees to comply with planned study procedures
- •Agrees to the collection of venous blood per protocol
- •Must agree to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (DVT) while hospitalized
排除标准
- •ALT or AST >5 times the upper limit of normal
- •History of blood clots
- •History of breast cancer
- •Allergy to progesterone or betacyclodextrin
- •Use of supplemental oxygen prior to hospital admission
- •Requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation
研究组 & 干预措施
Progesterone plus SOC
Progesterone 100 mg will be administered subcutaneously twice daily for 5 days in addition to institutional standard of care
干预措施: Progesterone 100 MG (Drug)
结局指标
主要结局
Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale
时间窗: 7 days
Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on high flow oxygen devices 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen 6. Not hospitalized, limitation on activities 7. Not hospitalized, no limitations on activities
次要结局
- Change in clinical status of subjects assessed daily while hospitalized and on Day 15(29 days)
- Duration of supplemental oxygen, mechanical ventilation (if applicable), and hospitalization(15 days)
研究者
Sara Ghandehari
Attending Physician, Internal Medicine/Pulmonary Medicine
Cedars-Sinai Medical Center